Medical Device
Manufacturing
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,486 records, page 878 of 1190
FDA device recalls, page 878 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1106-2011Spectrum Soft Central Venous Catheter Tray Minocyciine/Rifampin Antibiotic Impregnated...Cook IncorporatedFOZ
Z-1105-2011Cook Central Venous Catheter Tray, Triple Lumen Polyurethane, 5.0Fr/12cm...Cook IncorporatedFOZ
Z-1104-2011Cook Central Venous Catheter Tray, Triple Lumen Polyurethane, 5.0Fr/15cm...Cook IncorporatedFOZ
Z-1103-2011Cook Central Venous Catheter Tray, Triple Lumen Polyurethane, 5.0Fr/8cm, CUTLMY501JCCT...Cook IncorporatedFOZ
Z-1102-2011Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 5.0Fr/12cm...Cook IncorporatedFOZ
Z-1101-2011Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 5.0Fr/8cm, CUDLMY501JCCT...Cook IncorporatedFOZ
Z-1100-2011Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0Fr/12cm...Cook IncorporatedFOZ
Z-1099-2011Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0Fr/8cm...Cook IncorporatedFOZ
Z-1098-2011Spectrum Central Venous Catheter Tray, Minocydine/Rifampin Antibiotic Impregnated, Double...Cook IncorporatedFOZ
Z-1097-2011Spectrum Central Venous Catheter Tray, Minocydine/Rifampin Antibiotic Impregnated, Double...Cook IncorporatedFOZ
Z-1096-2011Peripherally Inserted Central Venous Catheter Tray Silicone, CPICSY401HOPKINS0911 00...Cook IncorporatedLJT
Z-0953-2011The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage...Stryker Corp.FQH
Z-0952-2011The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage...Stryker Corp.FQH
Z-0951-2011The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage...Stryker Corp.FQH
Z-0950-2011The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage...Stryker Corp.FQH
Z-0949-2011The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage...Stryker Corp.FQH
Z-0948-2011The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage...Stryker Corp.FQH
Z-0947-2011The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage...Stryker Corp.FQH
Z-0718-2011Mobilett XP Hybrid/Digital/CR Intended use: mobile x-ray systemSiemens Medical Solutions USA, Inc.IZL
Z-0606-2011Beaver-Visitec International (Beaver-Visitec) BD 1% OVD Sodium Hyaluronate, 10 mg/ml 1.0...Becton Dickinson & CoLZP
Z-0171-2011Mobilett XP and Mobilett XP Hybrid, Mobile radiology device System, x-ray, mobileSiemens Medical Solutions USA, Inc.IZL
Z-3113-2011DrugCheck, Distributed by Express Diagnostics Int'l Inc., 1550 Industrial Drive, Blue...Express Diagnostics Int'l., Inc.JXN
Z-2579-2011XiO Radiation Treatment Planning System, XiO Release 4.3.0 and above Used to create...Elekta LimitedMUJ
Z-0819-2011Depuy Spine Mountaineer OCT Spinal System Screw Caddy, Non Sterile Product Code...DePuy Spine, Inc.LRP
Z-0818-2011Depuy Spine Mountaineer OCT Spinal System Screw Caddy Set, , Non Sterile Product Code...DePuy Spine, Inc.LRP
Z-0817-2011Depuy Spine Mountaineer OCT Caddy Set, Non-Sterile Product Code: 2883-90-000 The...DePuy Spine, Inc.LRP
Z-2897-2011Aplio Artida Ultrasound Diagnostic System SSH-880CV. Toshiba American Medical Systems...Canon Medical Systems USA, Inc.IYN
Z-1548-2011The LIFEPAK12 Defibrillator/Monitor. The LIFEPAK12 Defibrillator/Monitor can be used in...Physio Control, Inc.MKJ
Z-0583-2011NDC, Inc. Pro Advantage Urine Analyzer, Catalog Number: Pro Advantage Urine Analyzer The...Teco DiagnosticsKQO
Z-0582-2011McKesson Medical Surgical 107-101 Urine Analyzer, Catalog Number: 107-101 The Uritek...Teco DiagnosticsKQO
Z-0581-2011Immunostics, Inc. Detector UriStrip Urine Analyzer, Catalog Number: Detector UriStrip...Teco DiagnosticsKQO
Z-0580-2011Henry Schein, Inc. OneStep Pro Urine Analyzer, Catalog Number: OneStep Pro Urine...Teco DiagnosticsKQO
Z-0579-2011Cole Taylor Marketing, Inc. CT-101 Urine Analyzer, Catalog Number: CT-101 The Uritek...Teco DiagnosticsKQO
Z-0578-2011Cliawaived, Inc. CLIA-101 Urine Analyzer, Catalog Number: CLIA-101 The Uritek TC-101...Teco DiagnosticsKQO
Z-0577-2011Teco Diagnostics Uritek TC-101 Urine Analyzer, Catalog Number: TC-101 The Uritek TC-101...Teco DiagnosticsKQO
Z-1952-2011ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500.ArthroCare CorporationMBI
Z-1592-2011Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including...Straumann USA, LLCLLZ
Z-1668-2011Abbott brand CELL-DYN Emerald Diluent Reagent, 10 mL, List Number: 09H48-02, Product is...Abbott MedicalGKZ
Z-2039-2011***REF MCA7-2SB***2 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment...The Anspach Effort, Inc.HTT
Z-2038-2011***REF MCA7-1SB*** 1 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment...The Anspach Effort, Inc.HTT
Z-2037-2011***REF MCA7-15SB*** 1.5 mm Fluted Ball, 7.3 cm. Use with Micro Curved...The Anspach Effort, Inc.HTT
Z-2036-2011***REF MCA5-2SB*** 2 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment...The Anspach Effort, Inc.HTT
Z-2035-2011***REF MCA5-15SB ***1.5 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment...The Anspach Effort, Inc.HTT
Z-2034-2011**REF MCA5-1SB*** 1 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA)...The Anspach Effort, Inc.HTT
Z-0827-2011ACUSON SC 2000 ultrasound system. Siemens Medical Solutions USA, Inc. Business Unit...Siemens Medical Solutions USA, Inc.IYN
Z-0826-20114Z1c matrix array transducer which is used with ACUSON SC2000 ultrasound system. Siemens...Siemens Medical Solutions USA, Inc.IYN
Z-0335-2011Medtronic Intrathecal Catheter Spinal Segment Revision Kit, 8598A. Method of...Medtronic NeuromodulationLKK
Z-0334-2011Medtronic Intrathecal Catheter, 8731SC with sutureless connector. Method of...Medtronic NeuromodulationLKK
Z-0454-2011DuraGen XS Dural Regeneration Matrix: 1 inch x 3 inches. Non Pyrogenic; Rx only;Integra...Integra LifeSciences CorporationGXQ
Z-0453-2011DuraGen XS Dural Regeneration Matrix: 5 inches x 7 inches. Non Pyrogenic; Rx only;Integra...Integra LifeSciences CorporationGXQ